BPN-Biologics Resources

 STTR and SBIR Omnibus program

BPN-Biologics

R43/R44 mechanism

U44 mechanism

Broad modalities of product development (including, but not limited to, small molecules, technologies, devices, biologics, etc.)

Limited to biologics development only (e.g., antibodies, peptides, proteins, oligonucleotide- and viral-based gene therapies, cell therapies, and other novel emerging therapies (e.g., microbial and microbiome therapies).

Indications are extremely broad

Indications are specified by participating institutes.

More competitive due to the number of applications

Not as competitive in terms of applications’ number

All stages of product development, no hard criteria for phase 1 entry.

Limited to the late stage of pre-clinical product development & optional clinical trials.

Budget is limited:
SBA hard cap -
Phase 1: $275,766 for (6 months-2 years)
Phase 2: $1,883,436 (2-3 years)
Waiver limits –
Phase 1: $700,00 for (cap of $500,000/year)
Phase 2: $3,000,000 (cap of $1,500,00)

Budget does not have a hard cap but should be within recommended frame:
Phase 1: up to $500K/year (up to 2 years)
Phase 2: up to 1.5M/year (no more than 3 years)

Granted funding

Granted funding + support (NIH experts, consultants and CROs contracted by NIH)

NIH scientific program staff do not collaborate on project activities after the award

After the award, NIH scientific program staff will assist, guide, coordinate, or participate in project activities

Milestones are only for Fast-Track mechanism (combined Phase I and Phase 2 award)

Milestones are set by Lead Development Team and must be met in order to move the project further. If milestones are not feasible to achieve, the project will be discontinued.

Can be used as a preparation stage prior the application to BPN-Biologics.

UG3/UH3 BPN-Biologics

U44 BPN-Biologics (SBIR Fast-track)

Eligibility: Higher Education Institutions, Non-profits, Local Governments, Federal Government Agencies, Small Businesses & Other For-Profit Organizations, Others.  

Eligibility: Only U.S. small business concerns (SBCs)

Additional support is available through SEED program for small business aspects

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

No specific requirements for PD/PI primary employment

The Project Director/Principal Investigator (PD/PI) must have his/her primary employment with the small business concern at the time of award and for the duration of the project period

UG3/UH3 projects are 100% funded by BPN-Biologics program and might have limitations due to funds availability

The funding of the grant comes from SBIR program, a Federally mandated set-aside, which can only fund small businesses.

Data sharing is essential

Data sharing is not mandatory; the data are protected for 20 years. See SBIR data right FAQ .

A commercialization plan is developed and updated over the course of the project.

A commercialization plan is expected in the application: a realistic plan (extending beyond the U44 Phase II) which outlines how and when full commercialization can be accomplished.